ABLE GLOVE LATEX POWDERED EXAMINATION GLOVES

• K Number: K063776
• Device Name: ABLE GLOVE LATEX POWDERED EXAMINATION GLOVES
• Manufacturer: BRIGHT ELEMENT SDN BHD
• Date Cleared: 2007-03-02 ( 71 days)
• Product Code: LYY
• Regulation Number: 880.6250
• Type: Traditional
• Panel: HO
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

A patient examination latex Powdered Gloves is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Device Description

LATEX POWDERED EXAMINATION GLOVES

AI/ML Overview

This document is a 510(k) premarket notification letter from the FDA regarding "Latex Powdered Examination Gloves." It does not contain information about acceptance criteria or a study proving that a device meets those criteria. This type of document is for a medical device that does not require clinical studies for market clearance.

Regulation Number and Section

§ 880.6250 Non-powdered patient examination glove.

(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.